Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery

NCT07062393 | Completed

• 1 other identifier: TSGH-MAR-SDM-2025
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial evaluates the effectiveness of Mobile Augmented Reality (MAR) counseling compared to traditional verbal counseling for patients undergoing thoracic surgery. MAR counseling integrates patient-specific 3D anatomical models to enhance understanding of surgical procedures and risks. The study assesses patient and caregiver satisfaction, decision-making confidence, and communication quality. Health care providers' perspectives on the counseling methods are also examined. Participants will be assigned to one of the two counseling groups and asked to complete a questionnaire immediately after the counseling session.

Conditions

Lung Cancer Patients

Keywords

Shared decision making; Patient education; Augmented reality

Outcome Measures

Primary Outcomes (1)

• Shared decision-making score

  Shared decision-making was evaluated using a validated questionnaire assessing patient perceptions of decision support, preparedness, and engagement. The total score ranges from 0 to 50, with higher scores indicating better shared decision-making.

  Immediately after counseling session (single timepoint)

Secondary Outcomes (1)

• Patient counseling preference

  Immediately after both counseling sessions

Study Arms (2)

Traditional First, Then MAR Counseling (T-M group)

EXPERIMENTAL

Participants receive traditional counseling first, followed by MAR counseling using a 3D mobile application.

Behavioral: Traditional Counseling → MAR Counseling

MAR First, Then Traditional Counseling (M-T group)

EXPERIMENTAL

Participants receive MAR counseling first using a mobile 3D model app, followed by traditional counseling with CT images and verbal explanations.

Behavioral: MAR Counseling → Traditional Counseling

Interventions

Traditional Counseling → MAR Counseling BEHAVIORAL

A single session begins with mobile augmented-reality counseling using interactive 3D models, followed by a standard verbal counseling with printed diagrams and CT images.

Traditional First, Then MAR Counseling (T-M group)

MAR Counseling → Traditional Counseling BEHAVIORAL

A single session begins with mobile augmented-reality counseling using interactive 3D models, followed by a standard verbal counseling with printed diagrams and CT images.

MAR First, Then Traditional Counseling (M-T group)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20 years and older
• Scheduled for elective thoracic surgery
• Able to understand written and spoken Mandarin
• Willing and able to provide informed consent
• Capable of completing questionnaires independently or with minimal assistance

You may not qualify if:

• Emergency surgery cases
• Severe cognitive impairment or psychiatric illness interfering with participation
• Visual or hearing impairments that prevent interaction with mobile devices
• Previous participation in a similar counseling trial
• Inability to complete follow-up procedures

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114202, Taiwan

Location

Related Publications (8)

• McDonald M, Shirk JD. The Effect of Digital Three-Dimensional Reality Models on Patient Counseling for Renal Masses. JSLS. 2023 Jan-Mar;27(1):e2022.00084. doi: 10.4293/JSLS.2022.00084.

  PMID: 36818764 BACKGROUND

• Arjomandi Rad A, Vardanyan R, Thavarajasingam SG, Zubarevich A, Van den Eynde J, Sa MPBO, Zhigalov K, Sardiari Nia P, Ruhparwar A, Weymann A. Extended, virtual and augmented reality in thoracic surgery: a systematic review. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):201-211. doi: 10.1093/icvts/ivab241.

  PMID: 34542639 BACKGROUND

• Deber RB, Kraetschmer N, Irvine J. What role do patients wish to play in treatment decision making? Arch Intern Med. 1996 Jul 8;156(13):1414-20.

  PMID: 8678709 BACKGROUND

• Braddock CH 3rd, Fihn SD, Levinson W, Jonsen AR, Pearlman RA. How doctors and patients discuss routine clinical decisions. Informed decision making in the outpatient setting. J Gen Intern Med. 1997 Jun;12(6):339-45. doi: 10.1046/j.1525-1497.1997.00057.x.

  PMID: 9192250 BACKGROUND

• Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.

  PMID: 12724430 BACKGROUND

• Lackey A, Donington JS. Surgical management of lung cancer. Semin Intervent Radiol. 2013 Jun;30(2):133-40. doi: 10.1055/s-0033-1342954.

  PMID: 24436529 BACKGROUND

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

  PMID: 31912902 BACKGROUND

• Chen YS, Hsu YC, Romalee W, Wang DH, Lai J, Huang TW, Lin KH. Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery: Randomized Clinical Crossover Trial. JMIR Mhealth Uhealth. 2025 Nov 13;13:e79632. doi: 10.2196/79632.

  PMID: 41069141 DERIVED

Study Officials

• Kuan-Hsun Lin, MD

  Tri-Service General Hospital, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This study employs a 2-period, 2-sequence crossover design in which all participants receive both interventions (traditional counseling and mobile augmented reality \[MAR\] counseling) in different sequences. Participants are randomly assigned to either the traditional-then-MAR group (T-M group) or the MAR-then-traditional group (M-T group). This design allows within-subject comparison of counseling effectiveness, minimizing individual variability.

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: July 15, 2022
• Primary Completion: June 19, 2023
• Study Completion: June 19, 2023
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)